Device with bendable distal portion and system actuating the distal portion of the device

ABSTRACT

A device with bendable distal end of its elongate body and a system actuating the distal portion of the device is disclosed. A rigid elongate member fixedly attached to a distal portion of a grip structure and forming a pathway for pull-wires, can be manipulated by a control organ, such that an angular displacement of the rigid elongate member within the hollow grip structure with respect to the distal portion of the grip generates bending of the distal portion of the elongate body. The device may further comprise a mechanism for immobilizing the rigid elongate member with respect to the grip in a selected position, such that the bent distal portion of the elongate body remains fixed in the selected position.

PRIORITY CLAIM

This application is a Continuation of application Ser. No. 16/247,485,filed Jan. 14, 2019, which claims the benefit of European PatentApplication No. 181516451, filed Jan. 15, 2018. These applications arehereby incorporated herein by reference.

FIELD OF THE INVENTION

The invention relates to devices with bendable distal end and systemactuating the distal end of the devices.

BACKGROUND OF THE INVENTION

Medical devices comprise pull-wires within their elongate body forenabling bending of their distal portion. The pull-wires extend from ahandgrip at the proximal portion of the elongate body to the distalflexible portion of the medical device, and the bending of the distalportion is controlled by a knob on the outside of the handgrip that isconnected through a mechanism, located inside the handgrip, to theproximal portion of the pull-wires. Such medical devices are oftencalled steerable medical devices, as bending of their distal portionallows steering of their distal end through a vessel network of apatient's body to a designated location for diagnosis and/or treatmentpurposes. Examples of medical device with steering mechanism usingpull-wires are disclosed in U.S. Pat. No. 6,485,455 B1 andUS2017/0333679 A1. Failure of the moving parts of the mechanism, usuallycomprising a rotatable cam or a pulley, or snapping of the pull-wiresfrom the mechanism, results in inability to use the steeringfunctionality of the medical device.

It remains a need to reduce complexity of the mechanism responsible forcontrolling the bending of the distal end of the medical device, therebyincreasing the reliability of the medical device, especially formultiple clinical uses.

SUMMARY OF THE INVENTION

It is an object of the present invention to reduce the complexity of themechanism responsible for controlling the bending of the distal end ofan elongate device.

According to a first aspect of the invention an elongate device isprovided with bendable distal end, comprising: an elongate body having adistal portion, a proximal portion and a lumen; a pull-wire locatedwithin the lumen, extending from the distal portion to the proximalportion of the elongate body and fixedly attached to the distal portioneccentrically with respect to a longitudinal axis of the elongate body;a hollow grip structure connected to the proximal portion of theelongate body; a rigid elongate member fixedly attached to a distalportion of the grip and forming a pathway for the pull-wire, wherein thepull-wire extends proximally from the rigid elongate member and isfixedly attached to a wall of the grip structure, wherein the rigidelongate member is configured for angular displacement within the hollowgrip structure with respect to the distal portion of the grip; a controlorgan for influencing the angular displacement of the rigid elongatemember.

The complexity of the mechanism responsible for controlling the bendingof the distal end of the medical device is reduced, thereby increasingthe reliability of the medical device, especially for multiple clinicaluses. The number of movable components of the steering mechanism isreduced, which reduces the chances for failure.

In an embodiment of the invention the device comprises two pull-wireslocated at opposite sides of a diagonal through the longitudinal axis ofthe elongate body, and the rigid elongate member is configured forangular displacement in a longitudinal plane comprising its longitudinalaxis. This embodiment enables bidirectional bending of the distalportion of the device, particularly to both sides of the longitudinalaxis of the elongate body.

In a further embodiment of the invention the device comprises three orfour pull-wires located equidistant from each other and equidistant fromthe longitudinal axis of the elongate body in a plane transversal to thelongitudinal axis of the elongate body. This embodiment enablesomnidirectional bending of the distal portion of the device, meaningthat the bending of the distal end can be controlled to any angle radialto the longitudinal axis of the elongate body.

In yet a further embodiment of the invention the diameter of thepull-wire is in the range of 0.025-0.15 mm and the diameter of theelongate body is in the range of 0.55-1.5 mm. The dimensions of thecomponents allow miniaturization of a device, in particular formanufacturing of micro-catheters for use in coronary or cerebralvasculature.

In an embodiment of the device according to the invention a distalportion of the grip extends along a predetermined length of the rigidelongate member, the distal portion of the grip is configured to followthe angular displacement of the rigid elongate member and to allowmovement of the distal portion of the grip with respect to a proximalmain body of the grip. The distal portion and the proximal main body ofthe grip can be a single-body grip of a particular material, for exampleplastic. The motion of the distal portion of the grip with respect tothe main body of the grip creates a resistance to the motion of thecontrol organ that influences the angular displacement of the rigidelongate member, thereby when the control organ is released, the rigidelongate member regains its neutral position causing the distal end ofthe elongate body to retrieve its neutral position.

In a further embodiment of the invention the inner cross section of thedistal portion of the grip is configured for press-fitting the rigidelongate member, and the inner cross section of the main body is atleast three times the inner cross section of the distal portion of thegrip. The difference between the inner cross sections is for controllingthe angular displacement stroke of the rigid elongate member, andthereby the bending radius of the distal portion of the elongate body.Press-fitting the rigid elongate member within the distal portion of thegrip creates the benefit of a good seal at the distal end of the grip,without use or extensive use of adhesives.

In an embodiment, the control organ is connected to the rigid elongatemember, and it is operable from an outer side of the grip, whereby thephysicians can control the bending of the distal end of the device in aconventional way. Alternatively, the control organ can be an extensionof the rigid elongate member distal to the grip structure. The benefitis that no additional opening is necessary on the body of the grip foraccommodating the control organ that needs to connect to the rigidelongate member.

In an embodiment, the distal portion of the elongate body comprises asensor connected to a control unit located within the grip. The sensor,which may be an ultrasound sensor, a pressure sensor, a flow sensor, apH sensor, a temperature sensor, an optical imaging sensor, a sensor formeasuring electrical signals or a combination of them, is controlled bythe control unit located within the grip, wherein the control unit isenergized by an integrated internal energy source or an external energysource.

In a further embodiment of the device the control unit is configured forwireless communication with an external processing unit for transmittingmeasurement information from the sensor to the external control unit.The benefit of the embodiment is that no connection cables are requiredbetween the device and the external processing unit for transfer ofmeasurement information.

In yet a further embodiment of the device, the elongate body, the grip,the connection of the elongate body to the grip and to the rigidelongate member are configured to form a closed system, whereby thedevice is leak-tight to liquids. The device can easily be madeleak-tight to liquids due to the fact that the grip requires only oneopening for connection of the elongate body to the grip through therigid elongate member, particularly at the distal end of the grip, wherethe rigid elongate member is either press-fit within the distal portionof the grip or alternatively glued. The angular displacement can becontrolled by the displacement of the distal extension of the rigidmember with respect to the proximal main body of the grip. The sensorsoptionally located at the distal portion of the elongate body andconnected to the control unit within the grip, wherein the control unitis configured for wireless transmission of the measurement informationto an external processing unit, also does not require additionalopenings on the grip. As result, a device leak-tight to liquid is easilyobtainable, which is advantageous for steerable devices for multipleclinical uses, where multiple reprocessing such as cleaning and/orsterilization of the device may involve liquids. Additionally, thecircumstances of the clinical use of the device may involvebody-liquids, e.g. blood, and the prevention of penetration ofbody-liquids in the device is important for devices for multiple uses.

In an embodiment of the invention the device comprises a mechanism forimmobilizing the rigid elongate member with respect to the grip in aselected position. Physicians often need to leave devices navigated to atarget location within the body, in order to advance additional devicesto the same location for diagnostic or for treatment purposes.Therefore, it is beneficial to leave the distal portion of the device inan immobilized position with respect to the structure of the anatomy,e.g. the distal portion of the device bent in a branch of a blood vesselaccording to the curvature of the branch, such that the distal portionof the device does not cause unnecessary stress to the blood vesselwall. The device with the fixable bending of the distal portion of theelongate body may be a guidewire, a diagnostic catheter or a treatmentcatheter.

In an embodiment, the mechanism comprises: a friction disc fixedlyattached to the proximal portion of the rigid elongate member; a firststructure fixed within the hollow grip at a position proximal to thefriction disc; a second structure movable within the hollow grip andlocated distal to the friction disc; a second control organ connected tothe movable second structure and operable from the outside of the wallof the grip. The second control organ may be a lever or a button that ismovable with respect to the grip and which causes the second structureto axially translate within the grip to press onto the friction disc andto press the friction disc onto the first structure, therebyimmobilizing the rigid elongate member. The motion of the second organmay combine rotation with translation to achieve the desired effect.

In another aspect of the invention a system is provided, comprising thedevice according to the invention and an apparatus configured to: claspthe grip and the control organ; and provide relative motion of thecontrol organ with respect to the grip based on a predetermined roadmap.The advantage is that the steering of the distal portion of elongatebody is automatized based on a predetermined roadmap, which may be fornavigation through a vessel network to a target location for diagnosticpurposes such as diagnostic of stenosis in coronary or cerebrovascularvessel, or for treatment of an anatomical organ such as a heart, whereinablations are required on multiples sites for treating cardiacarrhythmia.

In a further embodiment of the system the predetermined roadmap is basedon extracorporeal imaging of a vessel system and/or an anatomical organin a body. Imaging of anatomical structures may be performed by variouswell established techniques such as: radiological angiography (RA)including computed tomography angiography, magnetic resonanceangiography (MRA) or ultrasound imaging (UI). For the respective imagingmodalities also contrast agents are available for enhancing the featuresof the blood vessel system, for instance radiological contrast agent forRA, a gadolinium-based substance for MRA, echogenic contrast agentcomprising microbubbles for extracorporeal UI. The information of thevessel system and/or the anatomical organ is received by the apparatus,and a processor of the apparatus computes the required movements of thecontrol organ with respect to the grip, so that a target location withinthe vessel system can be reached, or multiple locations in an anatomicalorgan can be reached in a sequence for treatment, then subsequently theprocessor controls two arms of the apparatus that hold the control organand the grip for automatically navigating the distal portion of theelongate body to the predetermined target locations.

These and other aspects of the invention will be apparent from andelucidated with reference to the embodiments described hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

In the following drawings:

FIGS. 1A-1C illustrate schematically and exemplarily a first embodimentof the device according to the invention.

FIGS. 2A-2D illustrate schematically and exemplarily a second embodimentof the device according to the invention.

FIGS. 3A and 3B are photographs of the second embodiment of the deviceaccording to the invention.

FIG. 4 is a schematic and exemplary illustration of a third embodimentof the device according to the invention.

FIGS. 5A-5C illustrate schematically and exemplarily a fourth embodimentof the device according to the invention.

FIG. 6 is a schematic and exemplary illustration of a system for roboticcontrol of the device according to the invention.

FIG. 7 is a schematic and exemplary illustration of the system forrobotic control of the device based on predetermined roadmap.

DETAILED DESCRIPTION OF EMBODIMENTS

FIGS. 1A-1C schematically and exemplarily show a first embodiment of theelongate device with bendable distal end according to the invention. Thedevice 1 comprises: an elongate body 2 with a distal portion 21, aproximal portion 22 and having a lumen 23; a pull-wire 3 located withinthe lumen 23, extending from the distal portion 21 to the proximalportion 22 of the elongate body 2 and fixedly attached in the distalportion 21 eccentrically to the longitudinal axis of the elongate body2; a hollow grip structure 4 connected to the proximal portion 22 of theelongate body 2; a rigid elongate member 5 fixedly attached to a distalportion 41 of the grip 4 and forming a pathway for the pull-wire 3,wherein the pull-wire 3 extends proximally from the rigid elongatemember 5 and is fixedly attached to a wall of the grip structure 4,wherein the rigid elongate member 5 is configured for angulardisplacement 52 within the hollow grip 4 structure with respect to thedistal portion 41 of the grip 4; a control organ 51 for influencing theangular displacement 52 of the rigid elongate member 5. The gripstructure 4 is illustrated in the side view of the device in FIG. 1A.For the sake of clarity the grip is illustrated as it would be made of atransparent material, in order to allow depiction of the elements thatare located within the hollow grip. The grip structure may be made ofplastic or metal, in particular of thermoplastic material or alloys oflight metals. The rigid elongate member can be made of hypotube, inparticular of stainless steel. The elongate body of the device may bemade of thermoplastic material, in particular Pebax for medical devices.The distal portion 21 of the elongate body 2 may have a differentstiffness than the middle section, for allowing a different bendingprofile of the distal portion of the elongate body with respect to themiddle section. In clinical practice the distal portion 21 of theelongate body 2 has a lower hardness than the middle section of theelongate body, which can be obtained for example by heat-fusing Pebaxsections of different hardness grades. The control organ may be a leveror a button connected to the rigid elongate member 5, which can bemanipulated by a physician from the outer side of the grip 4 in order tocontrol the angular displacement of the rigid elongate member, resultingin a bending of the distal portion 21 of the elongate member 2.

FIG. 1B shows a cross section A-A of the elongate body of the embodimentillustrated in FIG. 1A, wherein two lumens 23 are present, and in whichtwo pull-wires 3 extend from the distal portion 21 of the elongate body2. The distal ends of the pull wires are fixedly attached with respectto the elongate body in its distal portion and the proximal ends of thepull-wires are fixedly attached to the wall of the grip structure 4. Thedevice comprises two pull-wires located at opposite sides of a diagonalthrough the longitudinal axis of the elongate body. This enablesbidirectional bending of the distal portion of the device, particularlyto both sides of the longitudinal axis of the elongate body. The effectis achieved by setting a position of the rigid elongate member 5 in aselected particular angle with respect to the longitudinal axis of thegrip structure 4 by a movement of the control organ 51, upon which theproximal end of the rigid elongate member 5 tenses one of the pull-wires3, such that the length of that particular pull-wire 3 extendingproximally from the rigid elongate member becomes longer and thereforethe length of that particular pull-wire extending distally to theproximal end of the rigid elongate member 5 becomes shorter. Since thepull-wire 3 is fixedly attached to the distal portion 21 eccentricallywith respect to the longitudinal axis of the elongate body 2, theshortening of the pull-wire 3 distal to the proximal end of the rigidelongate member 5 results in bending of the distal portion of theelongate body. The direction of bending of the distal portion of theelongate body is defined by the side to which the particular pull-wire,undergoing a tension due to the action of the rigid elongate member, isattached with respect to the longitudinal axis of the elongate body. Theattachment of the pull-wire in the distal portion of the elongate bodymay be accomplished by means of a ring fixed into the distal portion ofthe elongate body, and to which the distal end of the pull-wire iswelded or soldered. Alternatively, the distal end of the pull-wire canbe attached to the distal portion by local thermal reflow of the distalportion of the elongate body after insertion of the distal end of thepull-wire. Optionally, the distal end of the pull-wire may comprise astructure (e.g. hook, loop) for supporting fixation when encapsulated inthe material of the distal portion of the elongate body after localthermal reflow.

Although the pull-wires in FIGS. 1A-1C are located in separate lumens,in alternative embodiment the pull-wires may be located within a singlelumen. In a further alternative embodiment there is only one pull-wirein a single lumen of the elongate body, of which a distal end is fixedlyattached eccentrically to the elongate body. The device enablesunidirectional bending of the distal portion of the elongate body, andthe neutral position of the elongate body is regained by the resilienceof the material of the elongate body after manipulation of the controlorgan 51 is terminated. In yet a further alternative embodiment thedevice may comprise three or four pull-wires located equidistant fromeach other and equidistant from the longitudinal axis of the elongatebody in a plane transversal to the longitudinal axis of the elongatebody. The bending of the distal portion of the elongate body in all ofthe alternative embodiments is achieved in the manner described for theembodiment illustrated in FIGS. 1A-1C, by tensing at least one of thepull-wires by the angular displacement of the rigid elongate membercontrolled by the control organ.

FIG. 1C shows a cross section B-B of the device illustrated in FIG. 1A.The proximal portion 22 of the elongate body 2, comprising the lumens 23for hosting the pull-wires 3, is surrounded by the rigid elongate member5. The proximal portion 22 of the elongate body 2 may extend partiallyor fully within the rigid elongate member 5, and the elongate body isfixedly attached to the rigid elongate member either by press-fitting,by an adhesive or by a combination of the two. The distal portion 41 ofthe grip 4 surrounds the rigid elongate member 5, and the inner crosssection of the distal portion of the grip allows attachment to the rigidelongate member either by press-fitting, by an adhesive or by acombination of the two.

In the embodiment of the device illustrated in FIGS. 1A-1C the rigidelongate member 5 forms a pathway for the pull-wires 3, which extendproximally from the rigid elongate member 5 and are fixedly attached toa wall of the grip structure 4. This can be achieved by mechanicalattachment of the pull-wires to the grip for instance with screws or byinclusion of the proximal ends of the pull-wires within the structure ofthe grip during forming of the grip structure from a thermoplasticmaterial. The pull-wires are not restricted and not fixed along thelumen of the elongate body and along the rigid elongate member, as it isillustrated in the cross sections of FIGS. 1B and 1C, thus only thedistal and proximal ends of the pull-wires are fixed with respect to thedistal portion of the elongate body and the proximal main body 42 of thegrip structure, respectively. The inner cross section of the main body42 of the grip structure 4 is at least three times the inner crosssection of the distal portion 41 of the grip, in order to allowsufficient stroke for angular displacement 52 of the rigid elongatemember 5 within the proximal main body 42 of the hollow grip 4 withrespect to the distal portion 41 of the grip 4. The distal portion ofthe grip extends along a predetermined length of the rigid elongatemember, and follows the angular displacement of the rigid member. Inthis embodiment the grip structure is configured to allow movement ofthe distal portion of the grip with respect to the proximal main body ofthe grip. The distal portion and the proximal main body of the grip canbe a single-body grip of a particular material, for example plastic. Byvarying the thickness of the wall along the grip structure, e.g. thinwall at the proximal portion of the grip and thick wall for rigidity ofthe proximal main body of the grip, the distal portion of the gripallows movement with respect to the proximal main body of the grip for asingle-body grip structure. The motion of the distal portion of the gripwith respect to the proximal main body of the grip creates a resistanceto the motion of the control organ that influences the angulardisplacement of the rigid elongate member, thereby when the controlorgan is released, the rigid elongate member regains its neutralposition causing the distal end of the elongate body to retrieve itsneutral position. Alternatively, the distal portion 41 of the grip 4 maybe articulated with respect to the proximal main body of the grip, andthe grip can be made of multiple parts. For both alternatives, theportion of the grip that connects the distal portion of the grip 41 tothe proximal main body of the grip 42 acts as fulcrum for the rigidelongate member, with respect to which the angular displacement isachieved by manipulating the rigid elongate member 5 through operationof the control organ 51. As result, the angle formed by the longitudinalaxis of the rigid elongate member 5 with respect to the longitudinalaxis of the proximal main body 42 of the grip structure 4 can be changedthrough manipulation of the rigid elongate member 5 by the control organ51, which generates bending of the distal portion 21 of the elongatebody 2 directly related to the angle. When the longitudinal axes of therigid elongate member 5 and the proximal main body 42 of the gripstructure 4 coincide, then the distal portion 21 of the elongate body 2is in neutral position.

FIGS. 2A-2D schematically and exemplarily show a second embodiment ofthe elongate device with bendable distal end according to the invention,wherein the components similar to the already discussed first embodimentare referenced with identical numbers. The second embodiment of thedevice comprises four pull-wires located equidistant from each other andequidistant from the longitudinal axis of the elongate body in a planetransversal to the longitudinal axis of the elongate body, as it can beseen on FIGS. 2B-2D. In alternative embodiments the device may compriseone pull-wire eccentric to the longitudinal axis of the elongate body,or any other variation of multiple pull-wires, e.g. two, three, six,eight, located equidistant from each other and equidistant from thelongitudinal axis of the elongate body in a plane transversal to thelongitudinal axis of the elongate body. The control organ is anextension of the rigid elongate member 5 distal to the grip structure 4,as it can be seen also in the cross section B-B on FIG. 2C. The distalportion 53 of the rigid elongate member 5 extending distally from thedistal portion 41 of the grip structure 4 serves as control organ formanipulating the rigid elongate member with respect to the proximal mainbody 42 of the grip structure 4, in order to achieve the angulardisplacement of the rigid elongate member. The portion of the grip thatconnects the distal portion of the grip 41 to the proximal main body ofthe grip 42 acts as fulcrum for the rigid elongate member 5, withrespect to which the angular displacement is achieved by manipulatingthe rigid elongate member 5 through the control organ, being in thiscase the distal extension of the rigid elongate member. The attachmentand connection of components for the second embodiment and which arereferenced identically to the first embodiment illustrated in FIGS.1A-1C, may be achieved in identical or similar ways.

Photographs demonstrating the functional operation of the secondembodiment of the device are shown in FIGS. 3A and 3B. In FIG. 3A thedistal portion of the elongate body is in neutral position, whereas bymanipulating the distal extension of the rigid elongate member withrespect to the proximal main body of the grip structure in FIG. 3Bgenerates bending of the distal portion of the elongate body. The lengthof the elongate body may be in the range of 20 cm to 200 cm, dependingon the clinical application. For coronary and peripheral applicationsthe length of the elongate body is preferably between 120-200 cm. Formicrocatheters according to any of the embodiments of the device, andwhich are used in cerebrovascular or coronary applications, the diameterof the pull-wire can be in the range of 0.025-0.15 mm and the diameterof the elongate body can be in the range of 0.55-1.5 mm. For peripheralapplications or cardiac applications involving treatment of anomalies ofany of the cardiac chambers, the diameter of the elongate body may be upto 4 mm and the diameter of the pull-wire may be up to 0.25 mm. Theangle formed by the longitudinal axis of the rigid elongate member 5with respect to the longitudinal axis of the proximal main body 42 ofthe grip structure 4 can be changed through manipulation of the distalportion 53 of the rigid elongate member 5 with respect to the proximalmain body 42 of the grip 4, which generates bending of the distalportion 21 of the elongate body 2 directly related to the angle. Whenthe longitudinal axes of the rigid elongate member 5 and the proximalmain body 42 of the grip structure 4 coincide, then the distal portion21 of the elongate body 2 is in the neutral position.

Any of the embodiments of the device may comprise a sensor 61 on thedistal portion 21 of the elongate body 2, as shown if FIG. 4. The sensor61 is connected to a control unit 6 located within the grip 4. Thesensor, which may be an ultrasound sensor, a pressure sensor, a flowsensor, a pH sensor, a temperature sensor, an optical imaging sensor, asensor for measuring electrical signals or a combination of them, iscontrolled by the control unit 6 located within the grip, wherein thecontrol unit is energized by an integrated internal energy source or anexternal energy source. The control unit 6 may comprise a signalemitter/receiver 62 configured for wireless communication with anemitter/receiver 72 of an external processing unit 7 for transmittingmeasurement information obtained by the sensor 61. The benefit of theembodiment is that no connection cables are required between the deviceand the external processing unit for transfer of measurementinformation. The wireless communication also enables external control ofthe measurement parameters of the sensor if and when required. Theexternal processing unit is configured to output the measurement signalsto a display 71. The display may be integrated with the externalprocessing unit, or alternatively it may be a separate unit.

The elongate body, the grip structure, the connection of the elongatebody to the grip and to the rigid member are configured to form a closedsystem, whereby the device is leak-tight to liquids. The device caneasily be made leak-tight to liquids due to the fact that the griprequires only one opening for connection of the elongate body to thegrip through the rigid elongate member, particularly at the distal endof the grip, where the rigid elongate member is either press-fit withinthe distal portion of the grip or alternatively is glued. Alternativelyor additionally, the material of the grip may be of a plastic that uponlocal heating of its distal portion shrinks onto the rigid elongatemember. Any of these attachment techniques provide a leak-tight sealingof the grip. The angular displacement of the rigid elongate member canbe controlled by the displacement of the extension of the rigid elongatemember distal to the distal portion of the grip structure with respectto the proximal main body of the grip. The sensors optionally located atthe distal portion of the elongate body and connected to the controlunit within the grip, wherein the control unit is configured forwireless transmission of the measurement information to an externalprocessing unit, also does not require additional openings on the grip.As result, a device that is leak-tight to liquids can easily beobtained, which is advantageous for steerable devices for multipleclinical uses, where multiple reprocessing such as cleaning and/orsterilization of the device may involve liquids. Additionally, thecircumstances of the clinical use of the device may involvebody-liquids, e.g. blood, and the prevention of penetration ofbody-liquids in the device is important for devices for multiple uses.

Although the transversal profiles of the components of the devicesillustrated schematically and exemplarily in the Figs. are circular, inalternative embodiments any of the components may have transversalprofile according to a different geometrical form, such as oval, square,rectangular, hexagonal, etc.

In any of the embodiments of the device according to the invention thegrip may accommodate a mechanism for immobilizing the rigid elongatemember with respect to the proximal main body of the grip in a selectedposition. Physicians often need to leave devices, e.g. guidewire,diagnostic catheter or treatment catheter, navigated to a targetlocation within the body for advancing additional devices to the samelocation for diagnostic or for treatment purposes. Therefore, it isbeneficial to leave the device in an immobilized position with respectto the structure of the anatomy, e.g. in a branch of a blood vessel. Themechanism able to immobilize the rigid elongate member with respect tothe proximal main body of the grip in a selected position may also becalled braking mechanism. A schematic and exemplary embodiment of such abraking mechanism is shown is FIGS. 5A-5C, which comprises a frictiondisc 81 fixedly attached to the proximal portion of the rigid elongatemember 5; a first structure 82 fixed within the hollow grip 4 at aposition proximal to the friction disc 81; a second structure 83 movablewithin the hollow grip 4 and located distal to the friction disc 81; asecond control organ 84 connected to the movable second structure 83 andoperable from the outer side of the grip 4. The second control organ 84may be a lever or a button that is movable with respect to the grip andwhich causes the second structure 83 to axially translate within thegrip to press onto the friction disc 81 and to press the friction disc81 onto the first structure 82, thereby immobilizing the rigid elongatemember. The motion of the second control organ 84 may combine rotationwith translation to achieve the desired effect, such as illustrated inFIG. 5B. Both, the first structure 82 and the second structure 83 arehollow and the rigid elongate member 5 passes through their lumens, toallow the proximal ends of the pull-wires 3 to be fixedly attached tothe proximal main body 42 of the grip structure 4 proximal to the firststructure 82 of the immobilizing mechanism. The inner diameters of thefirst and second structures are dimensioned to allow angular movement ofthe rigid elongate member within the desired stroke, as can be observedin FIG. 5C. The diameter of the friction disc is smaller than the innerdiameter of the proximal main body of the grip, and since it is fixedlyattached to the rigid elongate member, its diameter limits the stroke ofthe angular displacement of the rigid elongate member. Additionally, awasher 85 that is not attached to the rigid elongate member 5 may beplaced between the first structure 82 and the friction disc 81, and/orbetween the friction disc 81 and the second structure 83. The innerdiameter of the washer 85 is dimensioned to allow angular movement ofthe rigid elongate member within the desired stroke, and its outerdiameter to allow free movement of the washer within the proximal mainbody of the grip structure. The first structure 82 may be fixedlyattached to the grip structure 4 by means of screw 86, by adhesive, orit may be part of the grip structure formed as a step with smaller innerdiameter with respect to the inner diameter of the proximal main body ofthe grip. The second control organ 84, which may be regarded as a brakecontrol element for immobilizing the rigid elongate member 5 in adesired position defined by a selected angular position of the rigidelongate member, projects through a slit within the grip structure orthrough a slit 87 of an annular brace 88 fixedly attached to the outersurface of the grip structure 4.

FIG. 6 illustrates an apparatus 9 for robotic manipulation of the device1. The apparatus comprises two arms 91, 92 configured for clasping thecontrol organ and the grip for influencing the angular displacement ofthe rigid elongate member. In FIG. 6 the control organ is the distalextension 53 of the rigid elongate member 5. In alternative embodiment,such as illustrated in FIG. 1A, the control organ 51 may be located onthe outer side of the grip structure 4. The arms 91, 92 provide movementfor relative motion of the control organ with respect to the grip basedon a preprogrammed roadmap.

The apparatus 9 may be part of a system used in an interventional roomin clinical practice, as schematically illustrated in FIG. 7. The system10 comprises an extracorporeal imaging apparatus 14 for imaginganatomical structures of a patient 11 placed on an interventional bed12. Any of the well-established imaging techniques may be used by theextracorporeal imaging apparatus, such as: RA, MRA or UI. For therespective imaging modalities also contrast agents are available forenhancing the features of the blood vessel system, for instanceradiological contrast agent for RA, a gadolinium-based substance forMRA, echogenic contrast agent comprising microbubbles for extracorporealUI. The information of the vessel system and/or the anatomical organ isreceived by the external processing unit 7, which may generate an outputof the received information for visualization on a display 71. Theexternal processing unit is configured to allow generation of a roadmapbased on the received extracorporeal imaging information either byinteraction of a physician or by automatic segmentation of the vesselsystem and/or the anatomical organ upon a selection of a clinicalprocedure. The physician may select via an interface coupled to theexternal processing unit an entry point into the vascular system and atarget location 13 within the body of the patient 11, where the distalend of the device needs to be navigated, based on the providedextracorporeal image. Alternatively or additionally, the physician maydefine a treatment scheme of an organ, e.g. ablation sites within achamber of the heart. The roadmap is transmitted from the externalprocessing unit through wired or wireless communication to the roboticmanipulation apparatus 9. The robotic manipulation apparatus computesthe relative movements of the two arms 91 and 92 with respect to eachother in order to provide the appropriate sequence of movements to thecontrol organ and the grip of the device in order to complete theactions predetermined by the physician or by the automatic segmentationaccording to the roadmap. The robotic manipulation apparatus 9 may beprovided with a translation stage for advancing the device 1 within thevasculature toward the target location, while simultaneous andsequential relative movements of the two arms provide steering of thedistal end of the device. In this manner the steering of the distalportion of the elongate body can be automatized, which is beneficial fornavigation through a vessel structure to a target location fordiagnostic purposes such as for diagnostic of stenosis in coronary orcerebrovascular vessel, or for treatment of an anatomical organ such asa heart wherein multiple ablations on subsequent sites are performed fortreating cardiac arrhythmia.

In the claims, the word “comprising” does not exclude other elements orsteps, and the indefinite article “a” or “an” does not exclude aplurality.

Any reference signs in the claims should not be construed as limitingthe scope.

What is claimed is:
 1. A grip apparatus for a medical device having anelongate body, wherein the elongate body comprises a pull-wire extendingthrough an internal lumen to a bendable distal end of the elongate bodysuch that tension on the pull-wire causes the bendable distal end of theelongate body to bend, the grip apparatus comprising: a grip housingconfigured to connect to a proximal portion of the elongate body,wherein the grip housing comprises a hollow interior; a rigid elongatemember configured to mate with the a proximal end of the elongate bodyand to provide a pathway for the pull-wire, wherein the pull-wireextends proximally through the rigid elongate member to the hollowinterior of the grip housing and is fixedly attached to a wall of thehousing within the hollow interior, wherein the rigid elongate member isconfigured for angular displacement within the hollow interior of thegrip structure that places tension on the pull-wire; and a control organextending through the wall in the grip structure to the rigid elongatemember, wherein an external pressure applied to the control organinfluences the angular displacement of the rigid elongate member,thereby producing tension on the pull-wire and bending the bendabledistal end.
 2. The grip apparatus according to claim 1, wherein themedical device comprises a second pull-wire extending from the distalend of the elongate body through the rigid elongate member and rigidlyfixed at a second angle to the interior portion of the wall in the gripstructure, wherein the second pull-wire is located on an opposite sideof a diagonal through the longitudinal axis of the elongate body fromthe pull-wire, and wherein the rigid elongate member is configured forangular displacement in a longitudinal plane comprising its longitudinalaxis that produces bending in the bendable distal end in at least twodifferent directions in response to pressure applied to the pull-wireand the second pull-wire.
 3. The grip apparatus according to claim 2wherein the pull-wire and the second pull-wire extend proximally throughthe rigid elongate member to the hollow interior of the grip housing ateccentric angles.
 4. The grip apparatus according to claim 2, whereinthe medical device comprises at least one additional pull-wire extendingfrom the distal end of the elongate body through the rigid elongatemember and rigidly fixed at a third angle to the interior portion of thewall in the grip structure, wherein the pull-wire, the second pull-wireand the at least one additional pull-wire are all located equidistantfrom each other and equidistant from the longitudinal axis of theelongate body in a plane transversal to the longitudinal axis of theelongate body, and wherein pressure applied to the rigid elongate memberproduces bending in the bendable distal end in at least three differentdirections in response to pressure applied to the pull-wire, the secondpull-wire and the at least one additional pull-wire.
 5. The gripapparatus according to claim 1, wherein the diameter of the pull-wire isin the range of 0.025-0.15 mm and a diameter of the elongate body is inthe range of 0.55-1.5 mm.
 6. The grip apparatus according to claim 1,wherein the distal portion of the grip structure extends along apredetermined length of the rigid elongate member, the distal portion ofthe grip structure is configured to allow movement of the distal portionof the grip structure with respect to a proximal main body of the gripstructure.
 7. The grip apparatus according to claim 6, wherein an innercross section of the distal portion of the grip structure is configuredfor press-fitting the rigid elongate member and wherein an inner crosssection of the proximal main body is at least three times the innercross section of the distal portion of the grip structure.
 8. The gripapparatus according to claim 1, wherein the control organ is connectedto the rigid elongate member and is operable from an outer side of thegrip structure.
 9. The grip apparatus according to claim 1, wherein thedistal portion of the elongate body comprises a sensor connected to acontrol unit located within the grip structure.
 10. The grip apparatusaccording to claim 8, wherein the control unit is configured forwireless communication with an external processing unit for transmittingmeasurement information from the sensor to the external processing unit.11. The grip apparatus according to claim 1, wherein the grip structure,the elongate body, a connection of the elongate body to the gripstructure and to the rigid elongate member are configured to form aclosed system, whereby the device is leak-tight to liquids.
 12. The gripapparatus according to claim 1, comprising a friction disc assemblyconfigured to immobilize the elongate body with respect to the gripstructure in a selected position.
 13. The grip apparatus according toclaim 12, wherein the friction disc assembly comprises: a friction discfixedly attached to a proximal portion of the elongate body; a firststructure fixed within the grip structure at a position proximal to thefriction disc; a second structure movable within the grip structure andlocated distal to the friction disc; a second control organ connected tothe second structure and operable from an outer side of the gripstructure.
 14. The grip apparatus according to claim I wherein thepull-wire extends proximally through the rigid elongate member to thehollow interior of the grip housing at an eccentric angle.
 15. A systemcomprising: a medical device comprising an elongate body having apull-wire extending through an internal lumen of the elongate body to abendable distal end such that tension on the pull-wire causes thebendable distal end of the elongate body to bend; and a grip apparatuscomprising: a grip housing configured to connect to a proximal portionof the elongate body, wherein the grip housing comprises a hollowinterior; a rigid elongate member configured to mate with the a proximalend of the medical device and to provide a pathway for the pull-wire,wherein the pull wire extends proximally through the rigid elongatemember to the hollow interior of the grip housing and is fixedlyattached to a wall of the housing within the hollow interior, whereinthe rigid elongate member is configured for angular displacement withinthe hollow interior of the grip structure that places tension on thepull-wire; and a control organ extending through the wall in the gripstructure to the rigid elongate member, wherein an external pressureapplied to the control organ influences the angular displacement of therigid elongate member, thereby producing tension on the pull-wire andbending the bendable distal end
 16. The system according to claim 15further comprising a clasp coupling the grip structure to the controlorgan, wherein the clasp is configured to provide relative movement ofthe control organ with respect to the grip structure based upon apredetermined roadmap.
 17. The system according to claim 16, furthercomprising an extracorporeal imaging unit and wherein the predeterminedroadmap is based upon extracorporeal imaging of a vessel system and/oran anatomical organ in a body.
 18. The system according to claim 15wherein the pull-wire extends proximally through the rigid elongatemember to the hollow interior of the grip housing at an eccentric angle.19. The system according to claim 15 comprising a friction disc assemblyconfigured to immobilize the rigid elongate member with respect to thegrip structure in a selected position.
 20. The system according to claim15, wherein the friction disc assembly comprises: a friction discfixedly attached to a proximal portion of the elongate body; a firststructure fixed within the grip structure at a position proximal to thefriction disc; a second structure movable within the grip structure andlocated distal to the friction disc; a second control organ connected tothe second structure and operable from an outer side of the gripstructure.